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Do Parkinson’s disease patients disclose their adverse events spontaneously?

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Background

Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson’s disease (PD).

Objective

To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient’s spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients.

Study design

Cross-sectional study.

Patients

Ambulatory, cognitively intact PD or post-stroke outpatients.

Interventions

None.

Outcome measures

Patients were first asked by means of an an open question to disclose any unpleasant effects in connection with their current medications that had occurred during the previous week. Afterwards, a predefined questionnaire listing the most common AEs known to be related to antiparkinsonian drugs was used to question the same patients in a systematic manner about the presence of any AE during the same week. Chronological and semiological criteria were used to classify the reported AEs as “unrelated” or “possibly/plausibly related” to the antiparkinsonian treatment.

Results

A total of 203 PD and 52 post-stroke patients of comparable age and sex were recruited. Eighty-five PD and five post-stroke patients reported spontaneously at least one AE (42 vs. 10%, p < 0.01), while 203 PD and 47 post-stroke patients reported at least one AE following the structured questionnaire (100 vs. 90%, p < 0.001). In PD patients, there were a total of 112 spontaneously reported AEs as compared with 1,574 according to the structured questionnaire (7%). Spontaneous disclosure of AEs was associated with experiencing >2 AEs [OR = 1.2 (1.1–3.2)], logistic regression). Seventy-four percent of PD patients had ≥1 AE possibly/plausibly related to antiparkinsonian drugs.

Conclusions

Results showed that only 7% of AEs were reported spontaneously by patients, thus underscoring the importance of systematically asking about AEs in PD patients.

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Acknowledgments

S.P.L.L. received an educational grant from the Association France-Parkinson (Paris, France) to conduct this study. We thank Dr. Jean-François Albucher for all his help with recruitment of post-stroke patients.

Conflicts of interest

S.P.L.L., M.V.R., N.F., U.S., and J.L.M. disclose no conflicts of interest. F.O. has received scientific grants from Novartis and Abott. O.R. has acted as an advisor for most drug companies developing antiparkinsonian medications and has received unrestricted scientific grants from GSK, Novartis, Boehringer-Ingelheim, Faust Pharmaceuticlas, Eisai, Lundbeck, TEVA, Euthérapie, and Solvay.

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Authors and Affiliations

  1. Laboratoire de Pharmacologie Médicale et Clinique, INSERM U 1027 Equipe de PharmacoEpidémiologie, Faculté de Médecine, Université de Toulouse, Toulouse, France

    Santiago Perez-Lloret, María Verónica Rey, Fabienne Ory, Jean-Louis Montastruc & Olivier Rascol

  2. Service de Pharmacologie Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de PharmacoEpidémiologie et d’Informations sur le Médicament, Centre Hospitalier Universitaire, Toulouse, France

    Santiago Perez-Lloret, María Verónica Rey, Fabienne Ory, Jean-Louis Montastruc & Olivier Rascol

  3. INSERM Centre d’Investigation Clinique CIC 9203, Toulouse, France

    Santiago Perez-Lloret, María Verónica Rey & Olivier Rascol

  4. Service de Neurologie et Explorations Fonctionnelles du Système Nerveux, CHU Rangueil, Toulouse, France

    Nelly Fabre

  5. Department of Neurology, University Hospital Bordeaux, Bordeaux, France

    Umberto Spampinato

  6. INSERM U862, Neurocentre Magendie, Bordeaux, France

    Umberto Spampinato

  7. Department of Clinical Pharmacology, Faculty of Medicine, University of Toulouse, 37 Allées Jules Guesde, 31000, Toulouse, France

    Santiago Perez-Lloret

Authors
  1. Santiago Perez-Lloret
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  2. María Verónica Rey
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  3. Nelly Fabre
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  4. Fabienne Ory
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  5. Umberto Spampinato
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  6. Jean-Louis Montastruc
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  7. Olivier Rascol
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Corresponding author

Correspondence to Santiago Perez-Lloret.

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Perez-Lloret, S., Rey, M.V., Fabre, N. et al. Do Parkinson’s disease patients disclose their adverse events spontaneously?. Eur J Clin Pharmacol 68, 857–865 (2012). https://doi.org/10.1007/s00228-011-1198-x

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  • DOI: https://doi.org/10.1007/s00228-011-1198-x

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